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Erdafitinib delivery system for bladder cancer treatment

Phase 1/2 Study of Erdafitinib Intravesical Delivery System (TAR-210) in Participants With Non-Muscle-Invasive or Muscle-Invasive Bladder Cancer

Phase1; Phase2 Interventional Janssen Research & Development, LLC · NCT05316155

This study is testing a new way to deliver Erdafitinib directly into the bladder to see if it can safely and effectively treat patients with localized bladder cancer.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment235 (estimated)
Ages18 Years and up
SexAll
SponsorJanssen Research & Development, LLC Industry-sponsored
Drugs / interventionsErdafitinib, radiation
Locations59 sites (Birmingham, Alabama and 58 other locations)
Trial IDNCT05316155 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of an intravesical delivery system for Erdafitinib, a pan-FGFR inhibitor, in patients with localized bladder cancer. It consists of multiple phases, including dose escalation and expansion, to determine the recommended Phase 2 dose and assess preliminary clinical activity. Participants with non-muscle invasive or muscle invasive bladder cancer with specific FGFR mutations or fusions will be enrolled. The goal is to provide targeted treatment while minimizing systemic side effects.

Who should consider this trial

Good fit: Ideal candidates include individuals with muscle-invasive or recurrent non-muscle-invasive bladder cancer who have FGFR mutations or fusions.

Not a fit: Patients without FGFR mutations or fusions or those with advanced bladder cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could offer a more effective and less toxic treatment option for patients with localized bladder cancer.

How similar studies have performed: Other studies have shown promise with FGFR inhibitors in bladder cancer, but this specific intravesical delivery method is a novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

Parts 1-3:

* Muscle-invasive or recurrent, non-muscle-invasive urothelial carcinoma of the bladder
* For selected Cohorts: Activating tumor pan-fibroblast growth factor receptor (FGFR) mutation or fusion, as determined by local or central testing, approved by the sponsor prior to the start of study treatment. Local tissue-based results (if already existing) from next-generation sequencing (NGS) or polymerase chain reaction (PCR) tests performed in Clinical Laboratory Improvement Amendments (CLIA) -certified or equivalent laboratories, or results from commercially available PCR or NGS tests
* Cohorts 1 and 2: Bacillus Calmette-Guérin (BCG) experienced, or participants with no BCG experience because BCG was not available as a treatment option in the participant's location within the previous 2 years and is currently unavailable. Participants who received an abbreviated course of BCG due to toxicity are still eligible
* Cohort 1 only: Refuses or is not eligible for radical cystectomy (RC)
* Cohorts 2 and 4: Willing and eligible for RC

Part 4:

* Have histologically confirmed diagnosis of recurrent Intermediate-risk-non-muscle invasive bladder cancer (IR-NMIBC) Ta LG tumors
* Must not have undergone tumor debulking or selective ablation of visible lesions; partial tumor biopsy to confirm diagnosis and provide tissue for biomarker testing is permitted as long as remaining tumor is at least 5 millimeter (mm) in size
* Must submit tissue and urine for FGFR testing
* Can have a prior or concurrent second malignancy which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment

Exclusion Criteria:

Parts 1-3:

* Concurrent extra-vesical (that is, urethra, ureter, renal pelvis) transitional cell carcinoma of the urothelium
* Prior treatment with an pan-fibroblast growth factor receptor (FGFR) inhibitor
* Received pelvic radiotherapy \<=6 months prior to the planned start of study treatment. If received pelvic radiotherapy greater than (\>)6 months prior to the start of study treatment, there must be no cystoscopic evidence of radiation cystitis
* Presence of any bladder or urethral anatomic feature that in the opinion of the investigator may prevent the safe use of Erdafitinib intravesical delivery system
* Indwelling urinary catheter. Intermittent catheterization is acceptable

Part 4:

* Histologically confirmed diagnosis of T1 NMIBC, HR NMIBC (HG/G2 or HG/G3 or CIS) or MIBC, locally advanced, non-resectable, or metastatic urothelial carcinoma at any time prior to enrollment. Previous high grade (HG) disease is accepted as long as diagnosis date is greater than or equal to (\>=5) years ago and there is documentation of low grade (LG) Ta thereafter
* Known allergies, hypersensitivity, or intolerance to any study component or its excipients
* Has a current diagnosis of newly diagnosed IR-NMIBC
* Received an investigational treatment for bladder cancer after Transurethral Resection of the Bladder Tumor (TURBT) for the current NMIBC diagnosis or within 4 weeks or the agent/therapy washout period, whichever is longer, before the planned first dose of study treatment, or is currently enrolled in an investigational study
* Evidence of current bladder perforation by cystoscopy or imaging

Where this trial is running

Birmingham, Alabama and 58 other locations

+9 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-Muscle Invasive Bladder NeoplasmsNon-Muscle Invasive Bladder CancerMuscle Invasive Bladder Cancer
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.